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FDA Warning Letters: Drug Residues Top List of Problems at Food Firms

Illegal drug residues in dairy cows slaughtered for meat were the main problem cited in recent warning letters from the U.S. Food and Drug Administration (FDA) to firms found in violation of regulations stipulated by the Food, Drug and Cosmetic Act.

Letters to four dairy producers warned that illegal levels of antibiotics and anti-inflammatory drugs had been found in the muscles and edible tissues of cows sold by the companies for slaughter. Other problems identified in recently posted warning letters included improper handling of acidified foods, improper handling of low-acid canned foods, unsanitary production conditions and misbranding of infant formula.

The firms whose product contained illegal levels of drugs included El-Vi Farms, LLC and Reuben R. Zimmerman, both of New York, Kelly Hills Dairy Inc. of Kansas and Noel D. Elmore of Kentucky.

FDA wrote to El-Vi Farms of Newark, NY, notifying the firm that samples of uncooked edible kidney tissue from a cow it sold for slaughter as food contained 4.16 parts per million (ppm) of ceftiofur, an animal antibiotic. This level was more than ten times the acceptable limit of .4 parts per million for this drug in edible kidneys.

The agency also found that E-Vi was administering ceftifur to animals in doses not authorized by the drug label and that it was not keeping proper treatment records for its animals.

Reuben R. Zimmerman, owner of his company bearing the same name, was warned that a cow sold for slaughter from his dairy facility contained .63 ppm of penicillin in its edible kidney tissue (the acceptable limit is .05 ppm), 1.3 ppm of the anti-inflammatory flunixin in its liver tissue, where the limit of the drug is .125 ppm, and .0293 ppm of flunixin in the muscle tissue, which can’t contain more than .025 ppm.

The Zimmerman facility was also found to be administering penicillin in doses not approved by its labeling and not keeping proper medical treatment records for its animals.

In its letter to Kelly Hills Dairy, Inc. of Seneca, KS, FDA notified the company that penicillin residues of .515 ppm in uncooked edible tissues of a dairy cow sold for slaughter.

FDA wrote to Noel Elmore Farms of Glasgow, KY, that said the company had sold a dairy cow for slaughter for use as food whose tissue samples contained levels of penicillin at .215 ppm in its kidney (the legal limit is .05 ppm).

The FDA investigation also found that on July 5, 2011, the company wrote a letter certifying that it was not marketing livestock with illegal drug residues. That letter covered the dairy cow whose tissue was later found to contain illegal levels of penicillin.

FDA also told all companies whose dairy cows contained illegal drug levels that they were using doses of drugs beyond what has been approved by their labels.

“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply,” said the agency to each of the firms.

FDA also wrote letters to other firms citing other food safety violations.

KIZ Foods Limited of Bhavnagar, India received a letter notifying it that it was not following regulations for the production of acidified foods.

Specifically, the company did not provide required records of its heat processing and control of pH, salt, sugar and preservative levels for its garlic past, ginger paste and ginger garlic paste to FDA. The firm also didn’t have personnel who have been certified in activities involving acidification, pH control, heat treatment and critical factors, another requirement.

FDA also found that KIZ did not conduct required pH testing, did not examine containers to make sure they are protected from contamination or leakage, did not mark product with a code identifying where and when it was produced, did not maintain equipment in a manner that will prevent it from contamination, did not clean food contact surfaces frequently enough and did not provide adequate hand washing facilities or hand drying stations for employees. Further, the firm did not take adequate steps to prevent pests from entering the facility and had not constructed its facility in a manner that allows for proper cleaning. 

FDA wrote to Vella Cheese Company of Sonoma, CA, telling the company it had not followed proper production requirements for low-acid foods. Specifically, the company had not registered with FDA as a commercial processor of low-acid foods, had not notified FDA of its processing methods, including sterilization procedures and temperature controls.

“Scheduled processes must be established by qualified persons having expert knowledge acquired through appropriate training and experience in the thermal processing of low-acid foods in hermetically sealed containers,” wrote FDA in its letter.

Finally, FDA wrote to Nestle Infant Nutrition informing the company its Gerber Good Start Gentle Infant Formula is misbranded because it made health claims not authorized by FDA. The product’s label claimed it helped “reduce risk of developing allergies” and that the 100% whey partially hydrolyzed it contains may reduce the risk of atopic dermatitis, statements that were not authorized by FDA.

They agency said Nestle Infant Nutrition already submitted a petition requesting to assert a link between the whey product and a reduced risk of allergy in infants because there was not sufficient scientific evidence to support the claim. The agency also said there is no evidence linking the specific whey product in the formula to reduced risk of atopic dermatitis, only linking whey-protein to the condition.

FDA said the packaging failed to include the required statement, in bold type: “should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.”

All companies who received these recent warning letters were asked to respond to the letter within 15 working days outlining steps they will take to correct these violations. 

Food Safety News

FDA Warning Letters: Misbranding, Inadequate HACCP Plans, Excessive Drug Residues

The latest round of warning letters from the U.S. Food and Drug Administration (FDA) include a dairy company cited for inaccurate nutritional claims, two seafood processors for inadequate HACCP plans, and three cattle producers for excessive drug treatments.

FDA found that Minerva Dairy in Minerva, OH, misbranded its Greek yogurt butter product labels by including inaccurate nutrient claims. The labels claim that the product is useful in maintaining healthy dietary practices, but its nutritional content does not meet requirements to make such a claim, FDA stated.

San Jose, CA-based seafood processor Il Pastaio Inc. was found to have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. FDA found that the firm did not have a HACCP plan for its frozen seafood ravioli products to control against the food safety hazards of pathogens, potential toxin formation, and undeclared allergens.

Another seafood producer, Prospect Enterprises in Los Angeles, CA, was also found to have violated the HACCP regulations for failing to provide evidence that its imported seafood products were processed under conditions equivalent to those required of domestic producers.

Mills Dairy Farm in Perrysville, OH, sold an animal for slaughter that was deemed adulterated for excessive levels of the drug florfenicol in the muscle, FDA stated. While the agency has established a tolerance of 0.3 parts per million of florfenicol in muscle, the sample from Mills Dairy Farm contained 3.62 ppm in the muscle. The farm was also cited for inadequate record-keeping of drug treatments.

Cattle producer Rex L. Jessee of New Tazewell, TN, was cited for excessive levels of a drug, sulfamethazine. An animal sold by Jessee was found to have 0.229 ppm of the drug in its liver, more than twice the legal tolerance of 0.1 ppm. Jessee was also cited for inadequate record-keeping of drug treatments.

Finally, FDA stated that Stoney Hill Farms of Saltsburg, PA, sold a bob veal calf for slaughter that tested for nearly three times the legal limit in its tissues of the drug dihydrostreptomycin. Stoney Hill was also cited for inadequate record-keeping of drug treatments.

Each company was given 15 days to respond to the concerns raised by FDA in the warning letters.

Food Safety News

FDA Warning Letters: Listeria, Rodents, Insects and Drug Residues

U.S. Food and Drug Administration (FDA) officials recently sent warning letters to owners of a pizza dough and cheese grating/repackaging facility in NY, a fortune cookie manufacturing plant in GA, a rice storage/milling facility in FL, two dairies in NY and one in OH.

Losurdo Foods Inc. of Hackensack, NJ, was a sent a letter Sept. 22 notifying the company of numerous problems at its facility in Amsterdam, NY, which produces frozen pizza dough, cannoli cream, bread crumbs and garlic spread, and it also grates and repackages various cheese products.

According to the FDA letter, an environmental sample collected on Feb. 19, 2014, confirmed that 18 of 72 environmental swabs taken at the facility were positive for Listeria monocytogenes.

“The positive swabs were collected from various locations within your Cheese Room and Bun Room which included direct food contact surfaces such as the sifter and cheese wheel cutting table,” the letter stated.

In addition, FDA asserted that hygienic practices and general cleanliness were inadequate at the facility, with employees’ clothing and bare arms in contact with food or packaging materials and the presence of both live and dead insects observed near manufacturing equipment. The agency also cited several violations of food-labeling regulations.

Poinciana Milling Complex Inc. was informed Sept. 17 that, after FDA inspections in June, July and August, its facility in Kissimee, FL, exhibited “gross insanity conditions” and violations of CGMP (Current Good Manufacturing Practice) regulations.

These included various live or dead insects “in, on, and near food stored throughout your facilities,” exposed totes of what appeared to be moldy rice stored outside the facility, and inadequately bonded or maintained seams on food-contact surfaces and milling equipment.

FDA sent a Sept. 17 warning letter to Well Luck Company Inc. of Jersey City, NJ, regarding problems observed during inspections from July 23-Aug. 7, 2014, at its fortune cooking manufacturing facility in Atlanta, GA.

The letter stated that live and dead mice and a dead rat were seen in traps at the facility. In addition, a mouse was seen running alongside the dock area. Rodent feces, urine and hair, along with evidence of gnawing, were also observed, FDA stated.

Further, the agency cited “live roach-like insects too numerous to count” along a wall in the fortune cooking processing room behind an ice machine and adjacent to stand mixers in use during production. At the same time, FDA acknowledged company efforts to clean the warehouse and otherwise improve maintenance of the facility.

On Sept. 22, Petrie Farms of Arcade, NY, was sent a warning letter noting that a bob veal calf sold for slaughter on Dec. 2, 2013, was later found to have 1.3 parts per million of desfuroylceftiofur (marker residue for ceftiofur) in its kidney tissues. FDA’s established tolerance for desfuroylceftiofur is 0.4 ppm. Therefore, this amount “causes the food to be adulterated” under federal law, the letter stated.

FDA sent Jerry Slabaugh of Kenton, OH, a warning letter on Sept. 16 stating that he had sold a bob veal calf for slaughter on or about Feb. 20, 2014. Analysis of the animal’s tissues later showed the presence of 0.123 ppm of sulfamethazine in the liver and the presence of tulathromycin in the kidney.

FDA’s established tolerance is 0.10 ppm for sulfamethazine residues; however, the agency has not established a tolerance for tulathromycin in the edible tissues of bob veal calves, the letter noted.

On Sept. 23, Double E Dairy LLC of Lowville, NY, was sent a warning letter by FDA stating that two bob veal calves were sold for slaughter which later were found to have unacceptable levels of neomycin residue in their kidney tissues. The first was found to have 9.83 ppm, while the second had 29.99 ppm.

The FDA tolerance level for neomycin in the kidney tissues of cattle is 7.2 ppm, but the letter noted that there is no acceptable level of residue associated with the use of neomycin in bob veal calves. Therefore, the presence of the drug causes the food to be adulterated, the letter stated.

In each letter, FDA requested that the recipients provide written responses detailing steps taken to bring them into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.

Recipients of the warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

Food Safety News

FDA Warning Letters: Listeria, Rodents, Insects and Drug Residues

U.S. Food and Drug Administration (FDA) officials recently sent warning letters to owners of a pizza dough and cheese grating/repackaging facility in NY, a fortune cookie manufacturing plant in GA, a rice storage/milling facility in FL, two dairies in NY and one in OH.

Losurdo Foods Inc. of Hackensack, NJ, was a sent a letter Sept. 22 notifying the company of numerous problems at its facility in Amsterdam, NY, which produces frozen pizza dough, cannoli cream, bread crumbs and garlic spread, and it also grates and repackages various cheese products.

According to the FDA letter, an environmental sample collected on Feb. 19, 2014, confirmed that 18 of 72 environmental swabs taken at the facility were positive for Listeria monocytogenes.

“The positive swabs were collected from various locations within your Cheese Room and Bun Room which included direct food contact surfaces such as the sifter and cheese wheel cutting table,” the letter stated.

In addition, FDA asserted that hygienic practices and general cleanliness were inadequate at the facility, with employees’ clothing and bare arms in contact with food or packaging materials and the presence of both live and dead insects observed near manufacturing equipment. The agency also cited several violations of food-labeling regulations.

Poinciana Milling Complex Inc. was informed Sept. 17 that, after FDA inspections in June, July and August, its facility in Kissimee, FL, exhibited “gross insanity conditions” and violations of CGMP (Current Good Manufacturing Practice) regulations.

These included various live or dead insects “in, on, and near food stored throughout your facilities,” exposed totes of what appeared to be moldy rice stored outside the facility, and inadequately bonded or maintained seams on food-contact surfaces and milling equipment.

FDA sent a Sept. 17 warning letter to Well Luck Company Inc. of Jersey City, NJ, regarding problems observed during inspections from July 23-Aug. 7, 2014, at its fortune cooking manufacturing facility in Atlanta, GA.

The letter stated that live and dead mice and a dead rat were seen in traps at the facility. In addition, a mouse was seen running alongside the dock area. Rodent feces, urine and hair, along with evidence of gnawing, were also observed, FDA stated.

Further, the agency cited “live roach-like insects too numerous to count” along a wall in the fortune cooking processing room behind an ice machine and adjacent to stand mixers in use during production. At the same time, FDA acknowledged company efforts to clean the warehouse and otherwise improve maintenance of the facility.

On Sept. 22, Petrie Farms of Arcade, NY, was sent a warning letter noting that a bob veal calf sold for slaughter on Dec. 2, 2013, was later found to have 1.3 parts per million of desfuroylceftiofur (marker residue for ceftiofur) in its kidney tissues. FDA’s established tolerance for desfuroylceftiofur is 0.4 ppm. Therefore, this amount “causes the food to be adulterated” under federal law, the letter stated.

FDA sent Jerry Slabaugh of Kenton, OH, a warning letter on Sept. 16 stating that he had sold a bob veal calf for slaughter on or about Feb. 20, 2014. Analysis of the animal’s tissues later showed the presence of 0.123 ppm of sulfamethazine in the liver and the presence of tulathromycin in the kidney.

FDA’s established tolerance is 0.10 ppm for sulfamethazine residues; however, the agency has not established a tolerance for tulathromycin in the edible tissues of bob veal calves, the letter noted.

On Sept. 23, Double E Dairy LLC of Lowville, NY, was sent a warning letter by FDA stating that two bob veal calves were sold for slaughter which later were found to have unacceptable levels of neomycin residue in their kidney tissues. The first was found to have 9.83 ppm, while the second had 29.99 ppm.

The FDA tolerance level for neomycin in the kidney tissues of cattle is 7.2 ppm, but the letter noted that there is no acceptable level of residue associated with the use of neomycin in bob veal calves. Therefore, the presence of the drug causes the food to be adulterated, the letter stated.

In each letter, FDA requested that the recipients provide written responses detailing steps taken to bring them into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.

Recipients of the warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

Food Safety News

FDA Warning Letters: Listeria, Rodents, Insects and Drug Residues

U.S. Food and Drug Administration (FDA) officials recently sent warning letters to owners of a pizza dough and cheese grating/repackaging facility in NY, a fortune cookie manufacturing plant in GA, a rice storage/milling facility in FL, two dairies in NY and one in OH.

Losurdo Foods Inc. of Hackensack, NJ, was a sent a letter Sept. 22 notifying the company of numerous problems at its facility in Amsterdam, NY, which produces frozen pizza dough, cannoli cream, bread crumbs and garlic spread, and it also grates and repackages various cheese products.

According to the FDA letter, an environmental sample collected on Feb. 19, 2014, confirmed that 18 of 72 environmental swabs taken at the facility were positive for Listeria monocytogenes.

“The positive swabs were collected from various locations within your Cheese Room and Bun Room which included direct food contact surfaces such as the sifter and cheese wheel cutting table,” the letter stated.

In addition, FDA asserted that hygienic practices and general cleanliness were inadequate at the facility, with employees’ clothing and bare arms in contact with food or packaging materials and the presence of both live and dead insects observed near manufacturing equipment. The agency also cited several violations of food-labeling regulations.

Poinciana Milling Complex Inc. was informed Sept. 17 that, after FDA inspections in June, July and August, its facility in Kissimee, FL, exhibited “gross insanity conditions” and violations of CGMP (Current Good Manufacturing Practice) regulations.

These included various live or dead insects “in, on, and near food stored throughout your facilities,” exposed totes of what appeared to be moldy rice stored outside the facility, and inadequately bonded or maintained seams on food-contact surfaces and milling equipment.

FDA sent a Sept. 17 warning letter to Well Luck Company Inc. of Jersey City, NJ, regarding problems observed during inspections from July 23-Aug. 7, 2014, at its fortune cooking manufacturing facility in Atlanta, GA.

The letter stated that live and dead mice and a dead rat were seen in traps at the facility. In addition, a mouse was seen running alongside the dock area. Rodent feces, urine and hair, along with evidence of gnawing, were also observed, FDA stated.

Further, the agency cited “live roach-like insects too numerous to count” along a wall in the fortune cooking processing room behind an ice machine and adjacent to stand mixers in use during production. At the same time, FDA acknowledged company efforts to clean the warehouse and otherwise improve maintenance of the facility.

On Sept. 22, Petrie Farms of Arcade, NY, was sent a warning letter noting that a bob veal calf sold for slaughter on Dec. 2, 2013, was later found to have 1.3 parts per million of desfuroylceftiofur (marker residue for ceftiofur) in its kidney tissues. FDA’s established tolerance for desfuroylceftiofur is 0.4 ppm. Therefore, this amount “causes the food to be adulterated” under federal law, the letter stated.

FDA sent Jerry Slabaugh of Kenton, OH, a warning letter on Sept. 16 stating that he had sold a bob veal calf for slaughter on or about Feb. 20, 2014. Analysis of the animal’s tissues later showed the presence of 0.123 ppm of sulfamethazine in the liver and the presence of tulathromycin in the kidney.

FDA’s established tolerance is 0.10 ppm for sulfamethazine residues; however, the agency has not established a tolerance for tulathromycin in the edible tissues of bob veal calves, the letter noted.

On Sept. 23, Double E Dairy LLC of Lowville, NY, was sent a warning letter by FDA stating that two bob veal calves were sold for slaughter which later were found to have unacceptable levels of neomycin residue in their kidney tissues. The first was found to have 9.83 ppm, while the second had 29.99 ppm.

The FDA tolerance level for neomycin in the kidney tissues of cattle is 7.2 ppm, but the letter noted that there is no acceptable level of residue associated with the use of neomycin in bob veal calves. Therefore, the presence of the drug causes the food to be adulterated, the letter stated.

In each letter, FDA requested that the recipients provide written responses detailing steps taken to bring them into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence.

Recipients of the warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

Food Safety News

Club, Dollar, Drug Channels Pace Retail Growth: Kantar

NEW YORK — Drug stores, dollar stores and membership warehouse clubs will be the fastest-growing retail formats during the next five years, according to a presentation by Kantar Retail here Wednesday.

Those three formats are expected to outpace Kantar’s projected 4.5% pace of overall retail sales growth by 2018. Supermarkets are projected to grow their sales by about 4.4% in the next five years, Kantar projected.

“One reason club stores and dollar stores will be successful is that they both do a good job curating product,” said Bryan Gildenberg, chief knowledge officer, Kantar Retail.

Drug stores, meanwhile, are in a “sweet spot” because of $ 15 billion in projected increases in spending on prescription drugs in 2014 through health care reform. That channel is expected to grow about 4.8% in the next five years.


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Health care reform is also expected to boost business at in-store climics, he said, noting that 30 million more people will be insured started next year, with no real increase in the number of doctors to treat them.

“In-store clinics will become a much bigger deal,” he said.

Brick-and-mortar retail sales overall — excluding online sales — are expected to grow at a 3.5% pace, Gildenberg said.

Kantar projected that retail square footage would grow about 1.5% in the next five years, with 60% of that coming from small-format stores like drug stores, dollar stores and convenience stores.

Online food sales are projected to increase from 1% of total food sales currently to about 5% of food sales by 2020.

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FDA to improve drug security with new system

The FDA is developing standards for a system that will help identify and trace certain prescription drugs as they’re distributed within the U.S.


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“The ultimate goal is to identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of the product, which will be an important tool in the fight against counterfeit drugs,” explained Ilisa Bernstein, deputy director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in a blog post.

The system will be interoperable, giving different stakeholders in the drug supply chain the ability to communicate and share information about a drug and its location, according to Bernstein.

Under the Drug Supply Chain Security Act, the FDA must issue draft guidance by Nov. 27, 2014, and many stakeholders must establish systems for compliance by Jan. 1, 2015.

The FDA has opened a docket in the Federal Register with questions for stakeholders about the systems they use to exchange information related to prescription drug transactions. The docket is open until April 21.

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FDA Warns NY Rancher About Potentially Harmful Drug Residues

The U.S. Food and Drug Administration has issued a warning letter to the owner of Riverview Ranch and Livestock in New York, after an investigation found that the operation sold an adulterated animal for slaughter for food.

The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) analyzed kidney tissue samples of a bob veal calf the ranch sold in April and found the presence of tulathromycin. FDA has not established a tolerance for residues of the antibiotic in the kidney tissue in preruminating calves.

The letter states that Riverview did not use the tulathromycin as directed by its approved labeling or by a veterinarian, resulting in the illegal drug residue.

In addition, the ranch failed to maintain treatment records of medicated animals that could keep potentially harmful drug residues from entering the food supply.

FDA directed the ranch to “take prompt action to correct the violations” and “establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.”

Food Safety News

Drug Stores Lead September Gains

NEW YORK — Sales at the nation’s drug stores rose 6% in September, leading all retail channels, according to a report Thursday from the International Council of Shopping Centers.

Overall, U.S. chain-store sales posted gains of 4% for the month, compared to year-ago results. Excluding gas, sales were actually up 5.1%.


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“The biggest story line here is that the September performance was led by the drug-store segment, posting its strongest monthly showing since April 2007,” said Michael P. Niemira, vice president of research and chief economist for ICSC. “This seemingly heralds the full recovery of this segment after an extended period of weakness due to several mitigating factors.”

In April 2007 the drug-store segment had a 6.7% sales gain. Apparel was the weakest performing segment in September, posting a 0.1% gain.

For October, ICSC research projects that comparable-store sales will increase between 3% and 4% — although the group cautioned that the federal government shutdown does have the potential to curb spending during the month, “biasing the October expectations to a slightly weaker performance even on the heels of a strong gain in September.”

The ICSC data combines comparable- or same-store sales and total store sales for publicly traded retailers to calculate an index.

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Drug Stores Lead September Gains

NEW YORK — Sales at the nation’s drug stores rose 6% in September, leading all retail channels, according to a report Thursday from the International Council of Shopping Centers.

Overall, U.S. chain-store sales posted gains of 4% for the month, compared to year-ago results. Excluding gas, sales were actually up 5.1%.


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“The biggest story line here is that the September performance was led by the drug-store segment, posting its strongest monthly showing since April 2007,” said Michael P. Niemira, vice president of research and chief economist for ICSC. “This seemingly heralds the full recovery of this segment after an extended period of weakness due to several mitigating factors.”

In April 2007 the drug-store segment had a 6.7% sales gain. Apparel was the weakest performing segment in September, posting a 0.1% gain.

For October, ICSC research projects that comparable-store sales will increase between 3% and 4% — although the group cautioned that the federal government shutdown does have the potential to curb spending during the month, “biasing the October expectations to a slightly weaker performance even on the heels of a strong gain in September.”

The ICSC data combines comparable- or same-store sales and total store sales for publicly traded retailers to calculate an index.

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Ahold Sues Drug Companies

QUINCY, Mass. — Ahold USA has filed suit against the makers of the drug Solodyn, citing “substantial losses” resulting from the drug maker’s attempts to keep the top-selling acne treatment from being available in cheaper generic form.

In a suit filed this week in U.S. District Court in Boston, Ahold alleged that Medicis, the maker of Solodyn, engaged in several illegal tactics to extend its monopoly on its patent for the drug, including paying generic manufacturers to delay introductions. Generic drug manufacturers Impax, Lupin and Teva Pharmaceuticals are named as co-defendants in the suit.

Ahold filed the suit on behalf of itself and a class of plaintiffs that would include any purchaser of Solodyn since Feb. 3, 2009. Plaintiffs, the suit said, “paid artificially inflated prices for minocycline hydrochloride extended release tablets and were deprived of the benefits of earlier and more robust competition from cheaper generic versions.”


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Ahold, which operates Stop & Shop and Giant chains in the U.S., did not specify the amount of damages it was seeking.

Medicis, a division of Valeant Pharmaceuticals, has not yet responded to the compliant.

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Loblaw to Buy Shoppers Drug Chain

TORONTO — Loblaw Cos. here on Monday said it has agreed to acquire Shoppers Drug Mart, Canada’s largest drug store chain, for about $ 11.9 billion (U.S.).

“This transformational partnership changes the retail landscape in Canada. With scale and capability, we will be able to accelerate our momentum and strengthen our position in the increasingly competitive marketplace,” said Galen G. Weston, executive chairman of Loblaw. “This combination creates a compelling new blueprint for the future, positioning us to capitalize on important trends in society, from the emphasis on health, wellness and nutrition, to the imperatives of value and convenience.”


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Loblaw said it would retain the Shoppers name and operate it as a separate division of Loblaw. Shoppers operates 1,242 Shoppers Drug Mart and Pharmaprix stores across Canada, and also also licenses or owns 57 medical clinic pharmacies operating under the name Shoppers Simply Pharmacy (Pharmaprix Simplement Santé in Québec) and six luxury beauty stores operating as Murale. Shoppers also owns and operates 62 Shoppers Home Health Care stores.

Loblaw said the acquisition gives it a “powerful footprint in the important and growing small-urban store sector.” It also said it would expand Shoppers’ offerings to include Loblaw’s private label and convenience food.

“We are delighted to partner with Loblaw to leverage our combined strengths,” said Domenic Pilla, president and chief executive officer of Shoppers Drug Mart. “For our shareholders, this transaction provides significant and immediate value, as well as the ability to benefit from future upside by virtue of their continued ownership of shares in the combined company.”

Loblaw said it would pay $ 33.18 (Canadian) in cash plus 0.5965 Loblaw common shares for each share of Shoppers.

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Survey shows increase in resistance to drug therapies among bovine respiratory disease cases

June 28, 2013 — A survey of records of bovine respiratory disease cases at the Kansas State Veterinary Diagnostic Laboratory showed that drug resistance in one of the primary pathogens that cause BRD, Mannheimia haemolytica, increased over a three-year period.

“We have been seeing an increase in the number of antibiotic resistant bacteria that cause pneumonia (also called BRD) in cattle,” said Brian Lubbers, assistant professor in the diagnostic lab, based at Kansas State University. “Many of these bacteria are resistant to, not one, but almost all of the antibiotics that we use to treat pneumonia in cattle.”

BRD is one of the most important diseases of feedlot cattle, particularly, said Lubbers, adding that the economic toll from the disease has been estimated to approach $ 1 billion annually in the United States alone, if one takes into account drug and labor costs, decreased production, and animal death losses.

Until now, one of the aspects that has not been studied very well is the cost linked to antimicrobial resistance in BRD cases, he said. To take a closer look, he and colleague Gregg Hanzlicek, also an assistant professor in the diagnostic lab, examined records of cases in which specimens of bovine lung tissue were submitted to the diagnostic lab over the three years, 2009 to 2011. Most of the cattle were from Kansas and Nebraska.

They found that over that period, a high percentage of M. haemolytica bacteria recovered from cattle lungs were resistant to several of the drugs typically used to treat that pathogen. The researchers also found, however, that no specimens were resistant to all six antimicrobial drugs.

The study was funded internally by the diagnostic lab.

Using resistance to three or more antimicrobials as the definition of multi-drug resistance, 63 percent of the bacteria would be classified as multidrug resistant in 2011, compared with 46 percent in 2010 and 42 percent in 2009.

The results of the study were published by the Journal of Veterinary Diagnostic Investigation.

“Antimicrobial resistance in veterinary medicine has received a considerable amount of recognition as a potential factor leading to antimicrobial resistance in human medicine,” Lubbers said. “However, the contribution of multidrug resistance to limited or failed therapy in veterinary patients has received much less attention.”

Because there are a limited number of antimicrobial drugs that can be used for treatment of BRD pathogens, Lubbers said, multidrug resistance in those pathogens poses a severe threat to the livestock industry.

“We (KSVDL) consider this type of information to be part of our active ongoing disease surveillance and will continue this work,” Lubbers said. “The questions of how these bacteria develop or where they come from, how widespread they are, and what is the impact on cattle production are still unanswered. We are actively seeking industry partners to investigate these questions.”

ScienceDaily: Agriculture and Food News